MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-01-19 for PRSVN MB TIB TRAY RM/LL CEM S4 149825004 manufactured by Depuy Orthopaedics, Inc., Depuy Cork Div.
[21394039]
The patient was revised because of loosening of the tibial baseplate.
Patient Sequence No: 1, Text Type: D, B5
[21437684]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2007-00226 |
| MDR Report Key | 807905 |
| Report Source | 05,07 |
| Date Received | 2007-01-19 |
| Date of Report | 2006-10-25 |
| Date of Event | 2006-10-25 |
| Date Mfgr Received | 2006-10-25 |
| Device Manufacturer Date | 2004-02-01 |
| Date Added to Maude | 2007-01-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | GINNY STAMBERGER, MGR |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727333 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS |
| Manufacturer Street | LOUGHBEG |
| Manufacturer City | RINGASKIDDY COUNTY, CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRSVN MB TIB TRAY RM/LL CEM S4 |
| Generic Name | 87MBD |
| Product Code | MBD |
| Date Received | 2007-01-19 |
| Model Number | NA |
| Catalog Number | 149825004 |
| Lot Number | 1032977 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 795390 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC., DEPUY CORK DIV |
| Manufacturer Address | LOUGHBEG RINGASKIDDY COUNTY, CORK EI |
| Baseline Brand Name | PRSVN MB TIB TRAY RM/LL CEM S4 |
| Baseline Generic Name | KNEE INSERT |
| Baseline Model No | NA |
| Baseline Catalog No | 149825004 |
| Baseline ID | NA |
| Baseline Device Family | PRSVN MB INSERT |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | Y |
| Premarket Approval | P9100 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-01-19 |